UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027190 |
|---|---|
| Receipt number | R000031159 |
| Scientific Title | The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD |
| Date of disclosure of the study information | 2017/04/29 |
| Last modified on | 2021/11/04 09:46:34 |
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Basic information
Public title
The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Acronym
The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Scientific Title
The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Scientific Title:Acronym
The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Region
| Japan |
Condition
Condition
COPD (Chronic obstructive pulmonary disease)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak FEV1 (post 1 hour inhalation with the combination of tiotropium and olodaterol or tiotropium)
Key secondary outcomes
1.Physical activity (triaxial accelerometer) on before and after 12 weeks treatment
2.Quality of life(CAT) on before and after 12 weeks treatment
3.Inspiratory capacity on before and after 12 weeks treatment
4.TDI scale (dyspnea) on before and after 12 weeks treatment
5.6MWD and modified Borg scale scores on before and after 12 weeks treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Interventions: combination treatment with tiotropium and olodaterol for 12 weeks
Interventions/Control_2
Control: treatment with tiotropium for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with COPD (FEV1/FVC<70%) and %FEV1<80%
2.Current or past smokers
3.Maintenance treatment naive patients
Key exclusion criteria
1.Patients who have bronchial asthma
2.Patients who are able to examine a pulmonary function test
3.Patients who are disturbed in walk ability or have a bone fracture
4.Patients who have experiences of exacerbation of COPD within 1 month
5.Patients with paroxysmal tachycardia (over 100 / min) and life threatening arrhythmia
6.Patients who have experiences of acute myocardial infarction or heart failure within 1 year
7.Patients who have experiences of malignant tumor ( excluding basal cell carcinoma or epithelial cancer of skin) within 5 years
8.Patients who do not understand purpose or method of the study
9.Patients with dementia
10.Patients who are being treated for depression and neurosis
11.Patients who have angle-closure glaucoma, benign prostatic hyperplasia with dysuria and hypersensitivity to atropine and its analogous substances or components of the drug
12.Patients who are judged not to be suitable as subjects
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Takahashi |
Organization
Saga University
Division name
Faculty of medicine, department of internal medicine, Division of respiratory medicine,
Zip code
8498501
Address
5-1-1 Nabashima, Saga, Saga Prefecture, JAPAN
TEL
0952-34-2369
takahak@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Takahashi |
Organization
Saga University
Division name
Faculty of medicine, department of internal medicine, Division of respiratory medicine,
Zip code
8498501
Address
5-1-1 Nabashima, Saga, Saga Prefecture, JAPAN
TEL
0952-34-2369
Homepage URL
takahak@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga university Clinical research center
Address
5-1-1, Nabeshima, Saga
Tel
0952343400
clinstudycenter@mail.admin.saga-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
佐賀大学医学部附属病院（佐賀県）Saga University Hospital
久留米大学病院（福岡県）Kurume University Hospital
国立病院機構福岡病院（福岡県）National hospital organization Fukuoka hospital
佐賀県医療センター好生館（佐賀県）Saga prefectural medical center Koseikan
地域医療推進機構佐賀中部病院（佐賀県）Japan Community Health Care Organization Saga central hospital
高邦会高木病院（福岡県）Kouhoukai Takagi hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.dovepress.com/first-line-treatment-with-tiotropiumolodaterol-improves-physical-activ-pee
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/first-line-treatment-with-tiotropiumolodaterol-improves-physical-activ-pee
Number of participants that the trial has enrolled
80
Results
Tiotropium/olodaterol treatment reduced the duration of physical activity with 1.0-1.5METs(regression coefficient,-43.6 [95%CI -84.1, -3.1], p=0.04)in a multiple regression model adjusted for cofounding factors such as age, FEV1, total CAT scores, 6MWD, and TDI.
Results date posted
| 2021 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included in 38 cases of T/O and 37 cases of T group. Mean age was 69.8 year old in T/O, 70.4 years old in T group.
Participant flow
These patients were randomized into T/O or T group.
Adverse events
There was no severe adverse events.
Outcome measures
They are evaluated pulmonary function, transitional dyspnea score, CAT score and physical activity before and after treatment for 12 weeks.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 29 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031159
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
